Author Interviews, Pharmacology, Pulmonary Disease, University of Michigan / 09.06.2017

MedicalResearch.com Interview with: Kevin R. Flaherty, M.D., M.S. Professor, Department of Internal Medicine Associate Director, T32 Multidisciplinary Training Program in Lung Diseases Chair, Pulmonary Fibrosis Foundation Clinical Care Network Steering Committee University of Michigan Medicine  MedicalResearch.com: What is the background for this study? What are the main findings? Response: This is a new post-hoc analysis, recently presented at the 2017 American Thoracic Society (ATS) conference, which sought to further assess the efficacy of Ofev (nintedanib), an FDA-approved drug treatment for idiopathic pulmonary fibrosis (IPF), and its effect on lung function in those with this disease. IPF is a rare and serious lung disease that causes permanent scarring of the lungs and affects as many as 132,000 Americans. The analysis examined pooled data from the two placebo-controlled, global Phase III INPULSIS trials, which evaluated the efficacy and safety of 52 weeks’ treatment with nintedanib in people with IPF. In both trials, a higher proportion of people treated with placebo than nintedanib had disease progression from baseline to week 52, as defined by the proportions of patients with ≥5% or ≥10% declines in lung function, as measured by forced vital capacity (FVC) % predicted. Additionally, a lower proportion of patients treated with placebo than nintedanib had no decline or an improvement in FVC % predicted. These data support the initial findings from the Phase III INPULSIS trials which found that more patients treated with nintedanib versus placebo had an absolute decline in FVC of less than 5%. In this subgroup analysis, we assessed the proportions of patients from the two INPULSIS trials treated with nintedanib and placebo who had no decline or an improvement in lung function from baseline to week 52 using pooled data for this post-hoc analysis. In terms of those who participated, a total of 864 patients were included (519 treated with nintedanib, 345 treated with placebo). Baseline characteristics including age, gender and FVC were similar between the subgroups of patients who had no decline or an improvement in FVC and those whose FVC declined, and between the nintedanib and placebo groups within each subgroup. (more…)
Author Interviews, Brigham & Women's - Harvard, NEJM, Ophthalmology / 08.06.2017

MedicalResearch.com Interview with: Elisabetta Patorno, MD, DrPH Assistant Professor of Medicine, Harvard Medical School Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? Response: Lithium, a widely used medicine to treat bipolar disorder, has been associated with a 400 fold increased risk of Ebstein’s anomaly, a congenital malformation of the heart, and a 5 fold increased risk of cardiac defects overall in infants when taken early in pregnancy, based on the results from the International Register of Lithium Babies in the 1970’s. Beyond this data, most of the information on the safety of lithium during pregnancy accumulated in the last 40 years is based on case reports and small studies with conflicting results. Despite these concerns and the limited information, lithium remains a first-line treatment for the 1% of women of reproductive age with bipolar disorder in the U.S. population, due to its recognized efficacy during pregnancy and the postpartum period, and due to the presence of a larger body of evidence showing increased risk of congenital malformations for other mood stabilizers, such as valproate. (more…)
Author Interviews, Cost of Health Care, JAMA, Nursing, University of Pittsburgh / 06.06.2017

MedicalResearch.com Interview with: Kristin Ray, MD, MS Assistant Professor Health Policy Institute University of Pittsburgh School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: We were interested in understanding how nurse practitioners and physician assistants are working with specialist physicians to provide specialty care. Much has been described and studied about nurse practitioners and physician assistants providing primary care, but the literature about their role in specialty care is more sparse. There have been many concerns over time about the supply of specialist physicians, heightening our interest in the role of nurse practitioners and physician assistants in working with specialist physicians. We focused on examining whether care to physician specialist's patients by nurse practitioners and physician assistants has increased over time as well as examining characteristics of patients seen by nurse practitioners and physician assistants. We found that visits with NPs and PAs for specialty care have increased over time, but remains a small fraction of specialty care overall. (more…)
ASCO, Author Interviews, Colon Cancer, Exercise - Fitness, Nutrition, UCSF / 06.06.2017

MedicalResearch.com Interview with: Dr. Erin Van Blarigan, ScD Assistant Professor, Department of Epidemiology and Biostatistics UC San Francisco MedicalResearch.com: What is the background for this study? Response: There are over 1.3 million colorectal cancer survivors in the United States. Cancer survivors often seek guidance on what they can do to lower their risk of cancer recurrence and death. In response to patient interest and the need for improved survivorship care, the American Cancer Society (ACS) published guidelines on nutrition and physical activity for cancer survivors. The guidelines are to: 1) achieve and maintain a healthy body weight; 2) engage in regular physical activity; and 3) achieve a dietary pattern that is high in vegetables, fruits, and whole grains. (more…)
Author Interviews, Brigham & Women's - Harvard, Gender Differences, JAMA, Mental Health Research / 05.06.2017

MedicalResearch.com Interview with: Carl G Streed Jr. M.D. Pronouns: he, him, his, himself Fellow, Division General Internal Medicine & Primary Care  Brigham & Women’s Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: The National Institutes of Health (NIH) has underscored the need to better understand the health of gender minorities, including transgender and gender non-conforming individuals. Prior investigations of gender minorities are limited by the lack of national gender identity data. In 2013, the Centers for Disease Control and Prevention (CDC) developed a gender identity question for the Behavioral Risk Factors Surveillance System (BRFSS); states had the option to administer this module beginning 2014. Our study aims to examine the health status of gender minorities in the US compared to cisgender peers. Compared to cisgender adults, gender minority adults are younger, less likely to be non-Hispanic white, married or living with a partner, have a minor child in the household, or be English speaking; but are more likely to have lower income, be unemployed, be uninsured, have unmet medical care due to cost, be overweight, and report depression. Gender minority adults, compared to cisgender adults, are more likely to report: poor or fair health; difficulty concentrating, remembering, or making decisions; and being limited in any way. These outcomes remained significant after adjustment. (more…)
Author Interviews, Dermatology, Genetic Research, Yale / 05.06.2017

MedicalResearch.com Interview with: Keith Adam Choate, MD, PhD, FAAD Associate Professor of Dermatology, Genetics and Pathology Director of Research, Dermatology Yale University School of Medicine New Haven, CT MedicalResearch.com: What is the background for this study? What are the main findings? Response:  Over the last 10 years, we have systematically been examining patients with ichthyosis to identify new genetic causes of this group of disorders.  We found that autosomal recessive mutations in KDSR cause ichthyosis and that the resulting skin disease is effectively treated with isotretinoin. (more…)
ASCO, Author Interviews, Cancer Research, NYU / 05.06.2017

MedicalResearch.com Interview with: Prof Francisco J Esteva MD PhD Director of the breast medical oncology program at Perlmutter Cancer Center. NYU Langone Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Trastuzumab is a monoclonal antibody directed against the human epidermal growth factor receptor 2 (HER-2). Trastuzumab therapy has been shown to improve survival in patients with early-stage and metastatic her-2 positive breast cancer. In this study, we compared the safety and efficacy of the trastuzumab originator (Herceptin) to a trastuzumab biosimilar (CT-P6) in patients with stage I-III HER-2 positive breast cancer receiving neoadjuvant chemotherapy. The study was a randomized phase III trial. We found the pathological complete response rates were similar in both groups. Both antibodies were safe. Pharmacokinetic studies showed similar plasma concentrations for the trastuzumab originator and the proposed biosimilar. (more…)
Author Interviews, Breast Cancer, Race/Ethnic Diversity, Surgical Research, University of Michigan / 01.06.2017

MedicalResearch.com Interview with: Elham Mahmoudi, PhD, MS Section of Plastic Surgery, University of Michigan Medical School Ann Arbor, Michigan MedicalResearch.com: What is the background for this study? What are the main findings? Response: About one-third of all women diagnosed with breast cancer undergo mastectomy. In recent years, owing to advancements in screening and treatment, life expectancy after being diagnosed with breast cancer has increased. Research has shown that for patients who undergo mastectomy, breast reconstruction offers many psychological benefits such as improved self-esteem, reduced sexual dysfunction, decreased anxiety, and overall improvement in quality of life. After the passage of the Women’s Health and Cancer Rights Act in 1998, the coverage of post-mastectomy breast reconstruction (PBR) by any type of health insurance became mandatory. However, there are large and widening racial and ethnic disparities in PBR, with White women having a higher rate of PBR than women from other racial and ethnic groups. In 2011, the State of New York enacted a law mandating that surgeons advise their patients undergoing mastectomy about available breast reconstruction options, insurance coverage, and referral to a plastic surgeon. We evaluated the effect of this law on racial/ethnic disparities in immediate PBR. Our results did not show any effect on the overall rate of immediate  post-mastectomy breast reconstruction or on disparities between white and African-American women; however, we found that White-Hispanic and White-other racial/ethnic group disparities in immediate PBR were reduced by 9 and 13 percentage points, respectively. This is a substantial reduction in disparity within only a year after the passage of the law, which demonstrates the importance of physician-patient communication. (more…)
Author Interviews, Infections, JAMA, UCLA / 31.05.2017

MedicalResearch.com Interview with: Gregory John Moran, MD, FACEP Emergency Medicine Dept. & Infectious Diseases Service UCLA Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: The bacterial etiology of cellulitis is difficult to determine because there is usually no material for culture, but streptococci are believed to be the most common etiology. Since the emergence of MRSA as a common cause of skin infections in the community, many clinicians add a second antibiotic with MRSA activity to an oral cephalosporin, such as a combination of cephalexin plus trimethoprim-sulfamethoxazole. It is unknown if there is an additional benefit to adding MRSA activity for treatment of cellulitis. This randomized, blinded trial compared cephalexin plus placebo to cephalexin plus trimethoprim-sulfamethoxazole for outpatient treatment of cellulitis without an abscess or wound. Bottom line: We did not find a benefit from addition of trimethoprim-sulfamethoxazole. (more…)
Author Interviews, Blood Pressure - Hypertension, Compliance, Cost of Health Care, University Texas / 31.05.2017

MedicalResearch.com Interview with: Kalyani B. Sonawane, PhD Assistant Professor/ PhD Program Director Department of Health Services Research, Management and Policy College of Public Health and Health Professions University of Florida Gainesville, FL 32610 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Almost one-third of Americans have high blood pressure. Of those patients who are prescribed medication to control their blood pressure, about 30 percent have problems with side effects and nearly 50 percent will not have their blood pressure controlled within the first year of taking medication. In such scenarios, physicians have the option to either add a medication, such as fixed-dose combination, to the patient’s regimen or gradually increase a patient’s dose of their current drug to achieve blood pressure control; and gradually decrease the dose of their current drug or switch to a different drug to resolve side effects. Using healthcare claims data, we compared the economic impact of these alternative treatment modification strategies. (more…)
Allergies, Asthma, Author Interviews, Brigham & Women's - Harvard, Social Issues / 31.05.2017

MedicalResearch.com Interview with: Wanda Phipatanakul, MD, MS Associate Professor of Pediatrics Harvard Medical School Director, Asthma Clinical Research Center Boston Children's Hospital Asthma, Allergy and Immunology Boston, MA 02115 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Observational studies have limitations in their ability to examine disparities in asthma, as these studies have relied on self-reported measures of medication use, asthma diagnosis, severity, outcomes, and access to care. Using data collected from a randomized controlled trial, we found that subjects with lower income had a significantly higher number of asthma treatment failures and asthma exacerbations, independent of race, BMI, education, perceived stress, baseline lung function, hospitalizations, inhaled corticosteroid adherence, inhaled corticosteroid dose, environmental allergen sensitization, and second-hand smoke exposure. (more…)
Author Interviews, Autism, Genetic Research, Schizophrenia, UCLA / 26.05.2017

MedicalResearch.com Interview with: Carrie Bearden, Ph.D. Professor, Departments of Psychiatry and Biobehavioral Sciences and Psychology Semel Institute for Neuroscience and Human Behavior University of California, Los Angeles MedicalResearch.com: What is the background for this study? What are the main findings? Response: A 22q11.2 deletion confers the highest known genetic risk for schizophrenia, but a duplication in the same region is strongly associated with autism and is less common in schizophrenia cases than in the general population. Thus, we became interested in trying to understand whether there were differences in brain development that might predispose to one condition vs. the other. (more…)
Author Interviews, Cannabis, Columbia, Dental Research / 26.05.2017

MedicalResearch.com Interview with: Jaffer A Shariff DDS MPH cert.DPH Periodontal Resident | Research Scientist Division of Periodontics, Columbia University College of Dental Medicine New York MedicalResearch.com: What is the background for this study? What are the main findings? Response: Marijuana use for both medical and recreational purposes has become increasingly common in recent years; it is the most commonly used recreational drug in the United States. Subsequent increase in its legalization among countries including the United States for recreational purposes, poses an emergent oral and periodontal health concerns. Our study revealed that frequent recreational marijuana users exhibited deeper periodontal probing depths, clinical attachment loss and higher odds of having severe periodontal disease than the non-frequent users, even after controlling for other risk factors linked to gum disease, such as cigarette smoking. (more…)
Author Interviews, Autism, Diabetes, McGill, Nature / 24.05.2017

MedicalResearch.com Interview with: Ilse Gantois, PhD Research Associate Dr. Nahum Sonenberg's laboratory Department of Biochemistry McGill University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Fragile X syndrome (FXS) is a neurodevelopmental disorder characterized by cognitive impairment and affects 1 in 4000 males and 1 in 6000 females. About 60% of persons with Fragile X also have autism spectrum disorder. FXS is caused by absence of Fragile X protein (FMRP), which results in hyperactivation of ERK (extracellular signal-regulated kinase) and mTORC1 (mechanistic target of rapamycin complex 1) signaling. We show that treatment with metformin, the most widely used FDA-approved antidiabetic drug, suppresses translation by inhibiting the ERK pathway, and alleviates a variety of behavioural deficits, including impaired social interaction and excessive grooming. In addition, metformin also reversed defects in dendritic spine morphogenesis and synaptic transmission. (more…)
Author Interviews, Dental Research, Heart Disease, Infections, Mayo Clinic / 24.05.2017

MedicalResearch.com Interview with: Daniel C. DeSimone, M.D. Infectious Diseases Fellowship, Year 2 Mayo Clinic MedicalResearch.com: What is the background for this study? Response: For over 50 years, the American Heart Association (AHA) has recommended antibiotics to be given to patients with certain cardiac conditions prior to invasive dental procedures (dental cleanings, extractions, root canals) with the hope to prevent infective endocarditis--a potentially deadly infection of the heart valves. Prevention of this infection was preferred to treatment of an established infection due to its high morbidity and mortality rates. However, in 2007, experts found that there was very little, if any, evidence that showed antibiotics prophylaxis prevented infective endocarditis prior to invasive dental procedures. Given this, the AHA revised its guidelines, significant reducing the number of patients where antibiotic prophylaxis would be given--as routine daily activities such as chewing food, tooth brushing, and flossing were much more likely to cause infective endocarditis than a single dental procedure. For over 50 years, patients with cardiac conditions that placed them at "moderate risk" and/or "high risk" were to receive antibiotics prior to dental procedures. In 2007, the "moderate risk" group were to no longer receive antibiotic prophylaxis. This is a significantly large proportion of patients--approximately 90% of all patients who would have received antibiotic prophylaxis. Given the drastic changes made in 2007, there was concern among the medical and dental communities about whether we were leaving patients "unprotected" and at risk for infective endocarditis. Thankfully, several population based studies from our group and others across the United States have not shown an increase in the rate of infective endocarditis. However, the question remained, "Are providers following the 2007 AHA guidelines?" and "Are patients still receiving antibiotics prior to dental procedures when its no longer indicated by the guidelines?". This was the main focus of our paper. We were able to go into the local dental offices and at the same time, have full access to their medical records. Every dental visit between 2005 and 2015 at their dental office was reviewed; the type of dental visit, whether they received antibiotic prophylaxis or not. In addition, we could confirm their cardiac conditions that would place them at "moderate risk" or "high risk" compared to the general population. (more…)
Author Interviews, Cocaine, McGill / 24.05.2017

MedicalResearch.com Interview with: Marco Leyton, Ph.D. Professor, Department of Psychiatry McGill University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Drug-related cues are potent triggers for eliciting conscious and unconscious desire for the drug. In people with severe substance use disorders, these cues also activate dopamine release in the dorsal striatum, a brain region thought to be involved in hard-to-break habits and compulsions. In the present study we found evidence that drug cues also activate this same dopamine response in non-dependent ‘recreational’ cocaine users. (more…)
Author Interviews, Geriatrics, JAMA, NYU, Primary Care / 22.05.2017

MedicalResearch.com Interview with: Benjamin Han, MD, MPH Assistant professor Departments of Medicine-Division of Geriatric Medicine and Palliative Care, and Population Health NYU Langone Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: There are an increasing number of older adults being prescribed statins for primary prevention, but the evidence for the benefit for older adults is unclear. Our study finds that in the ALLHAT-LLT clinical trial, there were no benefits in either all-cause mortality or cardiovascular outcomes for older adults who did not have any evidence of cardiovascular disease at baseline. (more…)
Author Interviews, Infections, UCLA / 22.05.2017

MedicalResearch.com Interview with: Dr. James A. McKinnell, MD LA BioMed Assistant Professor of Medicine David Geffen School of Medicine at UCLA MedicalResearch.com: What is the background for this study? Response: Pneumonia is the leading cause of death from infectious disease in the United States. We conducted this study because current community-acquired pneumonia guidelines from the American Thoracic Society and the Infectious Disease Society America, published in 2007, provide some direction about prescribing antibiotics for community-acquired pneumonia. But large-scale, real-world data are needed to better understand and optimize antibiotic choices and to better define clinical risk factors that may be associated with treatment failure. Antibiotic failure for community-acquired pneumonia is associated with substantial morbidity and mortality and results in significant medical expenditures. We examined databases containing records for 251,947 adult patients who were treated between 2011 and 2015 with a single class of antibiotics (beta-lactam, macrolide, tetracycline, or fluoroquinolone) following a visit to their physician for treatment for community-acquired pneumonia. We defined treatment failure as either the need to refill antibiotic prescriptions, antibiotic switch, ER visit or hospitalization within 30 days of receipt of the initial antibiotic prescription. (more…)
Author Interviews, Blood Pressure - Hypertension, Cleveland Clinic, Critical Care - Intensive Care - ICUs, Infections, NEJM / 22.05.2017

MedicalResearch.com Interview with: Ashish Khanna, MD, FCCP Assistant Professor of Anesthesiology, Cleveland Clinic Lerner College of Medicine Staff Intensivist Center for Critical Care and Department of Outcomes Research Cleveland Clinic, Cleveland MedicalResearch.com: How did you become interested in this topic? Response: Anesthesia forms the basis of my training but I also completed a fellowship in critical care and, at the present time, I do more work in critical care than anesthesia. About 75% of my time is spent in the Cleveland Clinic critical care units, including the Medical and surgical ICUs (Intensive Care Units). (more…)
Author Interviews, Gender Differences, UCLA, Weight Research / 22.05.2017

MedicalResearch.com Interview with: Arpana Gupta, Ph.D. Assistant Professor G. Oppenheimer Center for Neurobiology of Stress and Resilience Ingestive Behavior and Obesity Program Vatche and Tamar Manoukin Division of Digestive Diseases David Geffen School of Medicine, UCLA MedicalResearch.com: What is the background for this study? Response: Past studies have demonstrated how an imbalance in the processing of rewarding and salient stimuli results in maladaptive or excessive eating behaviors. However, stress and drug use are known to affect how sex and sex hormones modulate responses of the dopamine system involved in reward, and are thought to underlie sex differences in the pathophysiology of drug addiction and treatment response. These results suggest similar sex effects on the mesolimbic reward system may also be at play in obesity. (more…)
Author Interviews, BMJ, Brigham & Women's - Harvard, Outcomes & Safety / 21.05.2017

MedicalResearch.com Interview with: Yusuke Tsugawa, MD, MPH, PhD Harvard T. H. Chan School of Public Health Department of Health Policy and Management Cambridge, MA 02138 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Although evidence has suggested that older physicians may experience a decline in medical knowledge and are less likely to adhere to standard care, patients in general had a perception that older doctors are more experienced and therefore provide superior care. Using a nationally representative sample of Medicare beneficiaries who were hospitalized for medical conditions in 2011-2014, we found that patients treated by younger doctors have lower 30-day mortality compared to those cared for by older doctors, after adjusting for patient, physician, and hospital characteristics. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Emergency Care, Infections, NEJM, University of Pittsburgh / 21.05.2017

MedicalResearch.com Interview with: Christopher W. Seymour, M.D., M.Sc. Assistant professor of Critical Care Medicine and Emergency Medicine, and member of Clinical Research Investigation and Systems Modeling of Acute Illness University of Pittsburgh MedicalResearch.com: What is the background for this study? What are the main findings? Response: Following the tragic and widely publicized death of Rory Staunton, 12, from undiagnosed sepsis in 2012, New York became the first state to require that hospitals follow a protocol to quickly identify and treat the condition. The mandate led to widespread controversy in the medical community as to whether such steps would have saved Rory or anyone else’s life. Rory’s Regulations require hospitals to follow protocols for early identification and treatment of sepsis, and submit data on compliance and outcomes. The hospitals can tailor how they implement the protocols, but must include a blood culture to test for infection, measurement of blood lactate (a sign of tissue stress) and administration of antibiotics within three hours of diagnosis—collectively known as the “three-hour bundle.” We analyzed data from nearly 50,000 patients from 149 New York hospitals to scientifically determine if  Rory’s Regulations worked. We found that they did - 83 percent of the hospitals completed the bundle within the required three hours, overall averaging 1.3 hours for completion. For every hour that it took clinicians to complete the bundle, the odds of the patient dying increased by 4 percent. (more…)
Author Interviews, Education, Psychological Science, Technology, University of Pennsylvania / 21.05.2017

MedicalResearch.com Interview with: Jason Han, MD Resident, Cardiothoracic Surgery Hospital at the University of Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: The inspiration for this study comes from my personal experience as a medical student on clinical rotations. Despite having been a victim of a medical error while growing up myself, I found it extraordinarily difficult to admit to even some of my smallest errors to my patients and team. Perplexed by the psychological barriers that impeded error disclosure, I began to discuss this subject with my advisory Dean and mentor, Dr. Neha Vapiwala. We wanted to analyze the topic more robustly through an academic lens and researched cognitive biases that must be overcome in order to facilitate effective disclosure of error, and began to think about potential ways to implement these strategies into the medical school curriculum with the help of the director of the Standardized Patient program at the Perelman School of Medicine, Denise LaMarra. We ultimately contend that any educational strategy that aims to truly address and improve error disclosure must target the cognitive roots of this paradigm. And at this point in time, simulation-based learning seems to be the most direct way to do so, but also remain hopeful that emerging technologies such as virtual and augmented reality may offer ways for students as well as staff to rehearse difficult patient encounters and improve. (more…)
Abuse and Neglect, Blood Pressure - Hypertension, UT Southwestern / 21.05.2017

MedicalResearch.com Interview with: Wanpen Vongpatanasin, M.D. Professor of Medicine Norman & Audrey Kaplan Chair in Hypertension Fredric L. Coe Professorship in Nephrolithiasis and Mineral Metabolism Research Director, Hypertension Section, Cardiology Division, UT Southwestern Medical Center Dallas, TX 75390-8586 MedicalResearch.com: What is the background for this study? Response: It is well know that treatment of isolated systolic hypertension (ISH), a subtype of hypertension with elevated systolic BP 140 or above but normal diastolic BP of < 90 mmHg, improves cardiovascular outcomes in older adults after the sixth decade of life. However, it is controversial if ISH in young adults requires treatment because it was suggested that elevated systolic BP in these individuals are related to high stroke volume, rather than increased aortic stiffness. In earlier case series, ISH in young adults were particularly common in athletes with long arms and legs, suggesting that pulse wave amplification coupled with high stroke volume were responsible for elevated brachial systolic blood pressure but the true central BP was normal. Thus,  isolated systolic hypertension was proposed to be a spurious condition in young adults that can be ignored. However, previous studies used only indirect technique in assessing aortic structure and function. Furthermore, none of these studies were conducted in the U.S. Population. (more…)
Author Interviews, NEJM, OBGYNE, Yale / 21.05.2017

MedicalResearch.com Interview with: Hugh S. Taylor, M.D. Anitta O’keeffe Young Professor and Chair Departemnt of Obstetrics, Gynecology and Reproductive Sciences Yale School of Medicine Chief of Obstetrics and Gynecology Yale-New Haven Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Elagolix is an investigational, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that blocks endogenous GnRH signaling by binding competitively to GnRH receptors. Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone, while on therapy. Data from two replicate Phase 3 studies evaluating the efficacy and safety of elagolix were published in the New England Journal of Medicine. Elagolix demonstrated dose-dependent superiority in reducing daily menstrual and non-menstrual pelvic pain associated with endometriosis compared to placebo. At month three and month six, patients treated with elagolix reported statistically significant reductions in scores for menstrual pain (dysmenorrhea, DYS) and non-menstrual pelvic pain (NMPP) associated with endometriosis as measured by the Daily Assessment of Endometriosis Pain scale. The safety profile of elagolix was consistent across both Phase 3 trials and also consistent with prior elagolix studies. Ultimately, the studies showed that both elagolix doses (150 mg QD and 200 mg BID) were effective in improving dysmenorrhea, non-menstrual pelvic pain and quality of life over 6 months in women with endometriosis-associated pain. The elagolix safety/tolerability profile was consistent with the mechanism of action. (more…)
Author Interviews, JCEM, Surgical Research, Thyroid, University of Michigan / 18.05.2017

MedicalResearch.com Interview with: Megan Rist Haymart MD Assistant Professor University of Michigan MedicalResearch.com: What is the background for this study? What are the main findings? Response: Thyroid cancer is typically treated with thyroid surgery. It is common practice for physicians to inform patients that the risk of vocal cord paralysis or hypoparathyroidism with thyroid surgery is 1-3%. However, most of these estimates are based on single institution studies with high volume surgeons. In our study we evaluated surgical risks in a population-based cohort. Using the Surveillance, Epidemiology, and End Results-Medicare database, we found that 6.5% of thyroid cancer patients developed general post-operative complications (fever, infection, hematoma, cardiopulmonary and thromboembolic events) and 12.3% developed thyroid surgery specific complications (hypoparathyroidism/hypocalcemia, vocal cord/fold paralysis). Older patient age, presence of comorbidities, and advanced stage disease were associated with the greatest risks of surgical complications. (more…)
Author Interviews, Cancer Research, NYU, Smoking / 17.05.2017

MedicalResearch.com Interview with: Moon-shong Tang, PhD Professor of Environmental Medicine, Pathology and Medicine New York University Langone School of Medicine Tuxedo Park, New York 10987 MedicalResearch.com: What is the background for this study? Response: E-cigarettes (E-cigs) are designed to deliver the stimulant nicotine through aerosols, commonly referred as vapors. Nicotine is dissolved in organic solvents such as glycerin and propylene glycol. The nicotine is then aerosolized by controlled electric heating. E-cigs do not use tobacco leaves and E-cig smoke does not involve the burning process. Hence, E-cig smoke (ECS) contains only nicotine and the gas phase of the solvent. Because ECS contains neither carcinogens nor allergens or odors from the tobacco burning process, E-cigs have been promoted as an invention that can deliver a TS ‘high’ without TS negative effects. The population of E-cig users is rapidly rising, particularly in young adults. It has been estimated that 16% of high school students are E-cig smokers. Therefore, the health effects of E-cig smoke, particularly its carcinogenicity, deserve careful scrutiny. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care / 17.05.2017

MedicalResearch.com Interview with: Eric Roberts, PhD Post-doctoral fellow Department of Health Care Policy Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Increasing consolidation of health care providers has raised regulatory concerns that less competition will lead to higher health care prices and possibly lower quality care for patients. On the other hand, some industry observers have contended that larger and higher-priced practices are better able invest in systems to support care management, and ultimately, better patient care. In this study, we examined whether larger and higher-priced physician practices provided better and more efficient care to their patients. Higher-priced physician groups were paid an average of 36% more by commercial insurers, and were substantially larger than lower-priced practices located within the same geographic areas. Despite large differences in practices’ prices and size, we found few differences in their patients’ quality and efficiency of care. For example, when we compared patients who received care in high-priced versus low-priced practices, we found no differences in patients’ overall care ratings, physician ratings, access to care, physician communication, and use of preventive services. We also found no differences in patients’ hospital admissions or total spending, suggesting that higher-priced practices were not managing their patients’ care more efficiently than their lower-priced counterparts. We did find that patients in higher-priced practices were more likely to receive recommended vaccinations, review of their medications, and results of medical tests, and that they spent less time in the waiting room for a scheduled doctor’s appointment. However, once practice prices exceeded the average for their geographic area, we observed no further gains in quality on most of these measures. (more…)
AHA Journals, Author Interviews, Baylor College of Medicine Houston, Heart Disease, Lipids / 13.05.2017

MedicalResearch.com Interview with: Julia M. Akeroyd, MPH Center for Innovations in Quality, Effectiveness, and Safety (IQuESt) Michael E. DeBakey Veteran Affairs Medical Center Salim S Virani, MBBS, Ph.D. Baylor College of Medicine MedicalResearch.com: What is the background for this study? Response: In the recently published Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) trial, treatment with evolocumab resulted in a 15% relative (1.5% absolute) risk reduction of major cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD) at a median follow-up of 2.2 years. Given the high cost of evolocumab, there is a need to identify what proportion of ASCVD patients would qualify for evolocumab based on FOURIER entry criteria and how eligibility would change if maximal doses of evidence-based lipid lowering therapies were required. (more…)